WKN:889120 Bio-Rakete
07.12.04 02:36
#1
soros
WKN:889120 Bio-Rakete
Oh man,
könnte Kotzen, hatte diesen Wert mal bei etwa 1 USD gekauft und etwa 2 Jahre gehalten! Nun habe ich sie nicht mehr und ups! Netter Chart.
http://isht.comdirect.de/charts/...lors=0x000000&sSym=AKP.FSE&hcmask=
Gruß
Soros
WKN:889120
könnte Kotzen, hatte diesen Wert mal bei etwa 1 USD gekauft und etwa 2 Jahre gehalten! Nun habe ich sie nicht mehr und ups! Netter Chart.
http://isht.comdirect.de/charts/...lors=0x000000&sSym=AKP.FSE&hcmask=
Gruß
Soros
WKN:889120
28.02.11 16:34
#2
Mister G.
Hört, hört, 18,97 % seit Threadbeginn :o))
Scheint aber spannend zu werden, im Ami-yahoo trommeln sie.
http://messages.finance.yahoo.com/...mp;mid=22969&tof=1&frt=1
http://messages.finance.yahoo.com/...mp;mid=22969&tof=1&frt=1
21.12.11 12:11
#3
alice.im.börsenland
...
die letzten nachrichten zu anika.
http://www.stocknod.com/ANIK-Anika-Therapeutics-stock-news.aspx
http://www.stocknod.com/ANIK-Anika-Therapeutics-stock-news.aspx
16.04.12 15:07
#5
alice.im.börsenland
schade ariva...
news und artikel zu anika bekommt man nur in anderen foren...
http://finance.yahoo.com/q?s=ANIK
http://finance.yahoo.com/q?s=ANIK
25.03.15 09:21
#8
TasTea
Zusammenfassung 2014
Kurz Zusammengefaßt
- man hat Monovisc Jahresanfang 2014 eingeführt, dafür hat man im 1. und 2.Q eine Meilensteinzahlung von 17,5 plus 5 Mio $ bekommen
- man hat sich bis zum Jahresende einen Marktanteil von 2 % erwartet (hat man erreicht), innerhalb von 12 Monaten ist ein Marktanteil von 5 % geplant (USA)
- einen größeren internationalen Umsatzschub für Monovisc und Orthovisc erwartet man sich für 2015 ( in der Historie steht man hat erst seit 2013 ein Händlernetz mit 30 Partnern in 40 Ländern, auch hat man 2013 eine neue Produktionsstätte für das erwartete Wachstum errichtet)
- insgesamt beziffert man den Markt für diese Hyaluron viskose Produkte auf 2 Mrd $ bis 2018 möchte man einen Marktanteil von 15 % erreichen = ein Umsatz von 300 Mio $
- also müßte man jedes Jahr 50 Mio $ mehr Umsatz generieren, entspricht für 2015 einem Wachstum von 50 %
- man hat von 2013 auf 2014 durch die Neueinführung von Monovisc und Ausbau von Orthovisc einen Umsatzschub von 30 Mio $ erreicht, deshalb ist diese Zielvorgabe nicht unrealistisch
- in 2015 Jahresanfang kommt das neue Produkt Cingal auf den Markt - von dem sich der Geschäftsführer wieder einen ordentlichen Umsatzschub verspricht ( ich nehme an hier kommt zur Marteinführung wieder eine Meilensteinzahlung)
- dazu noch die weiteren Produkte Hyalospine und Hyalomatrix
- in der 2. Jahreshälfte 2015 erwartet man sich den Abschluß der Phase 3 Studie für das nächste Produkt Hyalofast - Markteinführung dann wohl Anfang 2016
- zu dem leichten Umsatzknick im 4. Q 2014, das begründet das Management mit dem Orderverhalten der Händler zum Jahresende (hat nichts wesentliches zu bedeuten)
Diese Infos erhält man alle aus der Historie bzw. aus den einzelnen Präsentationen zu den Quartalsberichten !!
http://www.anikatherapeutics.com/
- man hat Monovisc Jahresanfang 2014 eingeführt, dafür hat man im 1. und 2.Q eine Meilensteinzahlung von 17,5 plus 5 Mio $ bekommen
- man hat sich bis zum Jahresende einen Marktanteil von 2 % erwartet (hat man erreicht), innerhalb von 12 Monaten ist ein Marktanteil von 5 % geplant (USA)
- einen größeren internationalen Umsatzschub für Monovisc und Orthovisc erwartet man sich für 2015 ( in der Historie steht man hat erst seit 2013 ein Händlernetz mit 30 Partnern in 40 Ländern, auch hat man 2013 eine neue Produktionsstätte für das erwartete Wachstum errichtet)
- insgesamt beziffert man den Markt für diese Hyaluron viskose Produkte auf 2 Mrd $ bis 2018 möchte man einen Marktanteil von 15 % erreichen = ein Umsatz von 300 Mio $
- also müßte man jedes Jahr 50 Mio $ mehr Umsatz generieren, entspricht für 2015 einem Wachstum von 50 %
- man hat von 2013 auf 2014 durch die Neueinführung von Monovisc und Ausbau von Orthovisc einen Umsatzschub von 30 Mio $ erreicht, deshalb ist diese Zielvorgabe nicht unrealistisch
- in 2015 Jahresanfang kommt das neue Produkt Cingal auf den Markt - von dem sich der Geschäftsführer wieder einen ordentlichen Umsatzschub verspricht ( ich nehme an hier kommt zur Marteinführung wieder eine Meilensteinzahlung)
- dazu noch die weiteren Produkte Hyalospine und Hyalomatrix
- in der 2. Jahreshälfte 2015 erwartet man sich den Abschluß der Phase 3 Studie für das nächste Produkt Hyalofast - Markteinführung dann wohl Anfang 2016
- zu dem leichten Umsatzknick im 4. Q 2014, das begründet das Management mit dem Orderverhalten der Händler zum Jahresende (hat nichts wesentliches zu bedeuten)
Diese Infos erhält man alle aus der Historie bzw. aus den einzelnen Präsentationen zu den Quartalsberichten !!
http://www.anikatherapeutics.com/
25.03.15 09:24
#9
TasTea
value/ growth Anlayse im Peergroup Vergleich
ein Kauf !
http://seekingalpha.com/article/...sults-a-look-at-anika-therapeutics
A Growth Strategy With Extraordinary Results: A Look At Anika Therapeutics
Mar. 16, 2015 9:13 AM ET | About: Anika Therapeutics Inc. (ANIK) by: Arie Goren
Summary
I have developed a growth stocks selection strategy that can beat the market by a significant margin with lower risk.
A 16-year simulation of the strategy has given an annualized return of 21.72% while the S&P 500 index has increased only 3.22% during that period.
I also describe and recommend in this article one of the stocks selected by the strategy; Anika Therapeutics.
Usually, my investment strategy is based on buying a stock only after studying the company and analyzing the future prospects of its business. However, I have also developed some formulas for stock selection through screening and back-testing, and I have created some portfolios based on those formulas, some of them has turned out to be very successful. In my previous article from December 16, 2014, I described one of those strategies based on large cap stocks that are included in the S&P 500 index. The strategy is continuing to perform very well, and in one of my next articles, I will give an update information about the strategy. In this article, I will describe an even more successful strategy based on ten stocks that are included in the Russell 3000 index, and I will also focus on one of the companies; Anika Therapeutics (NASDAQ:ANIK).
For my portfolio, I have selected the top 10 Russell 3000 ranked stocks by a ranking system. Also, all the stocks have had to show increasing margins and increasing return on capital. Every two weeks, I rebalanced the portfolio by replacing the stocks whose ranks have deteriorated by new stocks with higher ranks. I cannot give here the detailed formula since it is quite complicated. However, I will give in a comment to this article the new list of stocks after each rebalance, and the total return. Next rebalance is on March 23. Although rebalancing each two weeks would seem to many investors as a difficulty, the annual turnover of this strategy is only 75%, and in many cases there is no need to change stocks each two weeks.
For the development of the strategy, I used Portfolio123's 16-year simulation capability that has given 16 years of annualized return of 21.72% for the strategy, while the S&P 500 index has increased only 3.22% during that period. Although I have found some strategies that have given even higher return, I have selected this strategy because it offers a lower risk. The maximum drawdown, which normally is much bigger in a small portfolio than in the benchmarks, was at 46.73% for the strategy, less than the 16-year maximum drawdown of the S&P 500 index which was 56.78%.
The charts below shows the 16-year simulation results.
I started this strategy, with real money, on December 01, 2014. The strategy has given a net gain of 10.41% until March 13 (commissions and fees were taken into account), while the S&P 500 index has not changed during that period as shown in Portfolio123's table below.
The current holdings of the portfolio are the following: Assured Guaranty (NYSE:AGO), Anika Therapeutics, DepoMed (NASDAQ:DEPO), Janus Capital (NYSE:JNS), St. Joe (NYSE:JOE), NASDAQ OMX (NASDAQ:NDAQ), Everest Re (NYSE:RE), REX American Resources (NYSE:REX), Universal Insurance (NYSE:UVE) and Waddell & Reed (NYSE:WDR).
(click to enlarge)
Anika Therapeutics
Despite reporting strong fourth quarter financial results on February 25 that were better than analyst estimates, Anika Therapeutics stock plunged 11.6% on the next trading day. It seems investors expected even better results.
Last quarter was the fourth quarter in a row that Anika beat earnings estimates, as shown in the table below.
Source: Yahoo Finance
Company
Anika Therapeutics develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. Its proprietary technology is based on hyaluronic acid, a naturally occurring, biocompatible polymer found throughout the body that is essential to joint health and tissue function. Anika's products range from orthopedic/joint health solutions led by Orthovisc and Monovisc; its multi- and single-injection treatments for osteoarthritis of the knee, to surgical aids in the ophthalmic and anti-adhesion fields. The company was founded in 1983 and is headquartered in Bedford, Massachusetts.
Latest Quarter Results
Anika's total revenue for the fourth quarter of 2014 was $23.3 million, compared with $21.3 million in the fourth quarter of 2013. For the full-year 2014, total revenue grew 41% to $105.6 million from $75.1 million a year earlier. Product revenue increased to $75.5 million in 2014 from $71.8 million in 2013.
Net income for the fourth quarter was up 17% to $7.8 million, or $0.51 per diluted share, from $6.7 million, or $0.44 per diluted share, in the year-earlier quarter. For full-year 2014, net income increased 86% to $38.3 million, or $2.51 per diluted share, from $20.6 million, or $1.39 per diluted share, in 2013.
In the company's earnings statement, Charles H. Sherwood, Ph.D., President and Chief Executive Officer said:
We achieved several key business milestones that position the Company well for continued success into the future. The exceptional clinical, regulatory and commercial milestones we accomplished in 2014 have set the stage for solid financial results in 2015 and accelerated profitable growth in future years.
Growth
Anika has recorded substantial growth in the last few years. The company's annual average sales growth over the last five years was at 21.4%, and the average EPS growth was extremely high at 51%. The estimated EPS growth for the next year is at 17.65%, and the average annual estimated EPS growth for the next five years is exceptionally high at 30%.
(click to enlarge)
Source: Fourth Quarter 2014 Investor Conference Call
In addition, ANIK's growth rates parameters have been much better than its industry median, its sector median and the S&P 500 median as shown in the table below.
(click to enlarge)
Source: Portfolio123
Valuation
ANIK's stock has underperformed the market in the last year. Since the beginning of 2014, ANIK's stock has gained only 4.2%, while the S&P 500 index has increased 11.1%, and the Nasdaq Composite Index has risen 16.6%. However, ANIK was a big winner in 2013, gaining an astounding 283.9% in the year, while the S&P 500 index has increased 29.6%, and the Nasdaq Composite Index has risen 38.3% in that year.
(click to enlarge)
Chart: TradeStation Group, Inc.
ANIK's valuation metrics are excellent, the company has no debt at all, and its quick ratio is extremely high at 21.1. Furthermore, its enterprise value/EBITDA ratio is very low at 7.32, and its PEG ratio is exceptionally low at 0.53.
In addition, ANIK's margins parameters have been much better than its industry median, its sector median and the S&P 500 median as shown in the table below.
(click to enlarge)
Source: Portfolio123
Looking Forward
Anika's development pipeline is strong with an increased focus on regenerative medicine and product concepts that have the potential to expand its market opportunities dramatically. The company has two new products, Cingal and Hyalofast advancing toward full commercialization. Its Phase III trial for Hyalofast is scheduled to begin this year and with CE mark approval for Cingal likely in hand by year end, Anika is turning its attention to commercialization and the potential for revenue from Cingal beginning within the next 18 months. In addition, Anika continues to develop patent applications and receive patent approvals based primarily on the HYAFF technology that it acquired with its Italian subsidiary Anika S.r.l. The company was awarded five such patents in 2014. One of them, for example, is directed to meniscus repair and regeneration while another was for spinal anti-adhesion application. According to the company, its prospects have never been brighter as it begins 2015.
Summary
Anika's development pipeline is strong with an increased focus on regenerative medicine and product concepts that have the potential to expand its market opportunities dramatically. The company has recorded substantial growth in the last few years, and its future growth prospects are extremely high. Moreover, Anika has compelling valuation metrics; its enterprise value/EBITDA ratio is very low at 7.32, and its PEG ratio is exceptionally low at 0.53. In my opinion, ANIK's stock has plenty of room to grow, and it is a Buy right now.
Source: A Growth Strategy With Extraordinary Results: A Look At Anika Therapeutics
Disclosure: The author is long ANIK, AGO, DEPO, JNS, JOE,NDAQ, RE, REX, UVE, WDR. (More...)The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.
Share this article with a colleague
http://seekingalpha.com/article/...sults-a-look-at-anika-therapeutics
A Growth Strategy With Extraordinary Results: A Look At Anika Therapeutics
Mar. 16, 2015 9:13 AM ET | About: Anika Therapeutics Inc. (ANIK) by: Arie Goren
Summary
I have developed a growth stocks selection strategy that can beat the market by a significant margin with lower risk.
A 16-year simulation of the strategy has given an annualized return of 21.72% while the S&P 500 index has increased only 3.22% during that period.
I also describe and recommend in this article one of the stocks selected by the strategy; Anika Therapeutics.
Usually, my investment strategy is based on buying a stock only after studying the company and analyzing the future prospects of its business. However, I have also developed some formulas for stock selection through screening and back-testing, and I have created some portfolios based on those formulas, some of them has turned out to be very successful. In my previous article from December 16, 2014, I described one of those strategies based on large cap stocks that are included in the S&P 500 index. The strategy is continuing to perform very well, and in one of my next articles, I will give an update information about the strategy. In this article, I will describe an even more successful strategy based on ten stocks that are included in the Russell 3000 index, and I will also focus on one of the companies; Anika Therapeutics (NASDAQ:ANIK).
For my portfolio, I have selected the top 10 Russell 3000 ranked stocks by a ranking system. Also, all the stocks have had to show increasing margins and increasing return on capital. Every two weeks, I rebalanced the portfolio by replacing the stocks whose ranks have deteriorated by new stocks with higher ranks. I cannot give here the detailed formula since it is quite complicated. However, I will give in a comment to this article the new list of stocks after each rebalance, and the total return. Next rebalance is on March 23. Although rebalancing each two weeks would seem to many investors as a difficulty, the annual turnover of this strategy is only 75%, and in many cases there is no need to change stocks each two weeks.
For the development of the strategy, I used Portfolio123's 16-year simulation capability that has given 16 years of annualized return of 21.72% for the strategy, while the S&P 500 index has increased only 3.22% during that period. Although I have found some strategies that have given even higher return, I have selected this strategy because it offers a lower risk. The maximum drawdown, which normally is much bigger in a small portfolio than in the benchmarks, was at 46.73% for the strategy, less than the 16-year maximum drawdown of the S&P 500 index which was 56.78%.
The charts below shows the 16-year simulation results.
I started this strategy, with real money, on December 01, 2014. The strategy has given a net gain of 10.41% until March 13 (commissions and fees were taken into account), while the S&P 500 index has not changed during that period as shown in Portfolio123's table below.
The current holdings of the portfolio are the following: Assured Guaranty (NYSE:AGO), Anika Therapeutics, DepoMed (NASDAQ:DEPO), Janus Capital (NYSE:JNS), St. Joe (NYSE:JOE), NASDAQ OMX (NASDAQ:NDAQ), Everest Re (NYSE:RE), REX American Resources (NYSE:REX), Universal Insurance (NYSE:UVE) and Waddell & Reed (NYSE:WDR).
(click to enlarge)
Anika Therapeutics
Despite reporting strong fourth quarter financial results on February 25 that were better than analyst estimates, Anika Therapeutics stock plunged 11.6% on the next trading day. It seems investors expected even better results.
Last quarter was the fourth quarter in a row that Anika beat earnings estimates, as shown in the table below.
Source: Yahoo Finance
Company
Anika Therapeutics develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. Its proprietary technology is based on hyaluronic acid, a naturally occurring, biocompatible polymer found throughout the body that is essential to joint health and tissue function. Anika's products range from orthopedic/joint health solutions led by Orthovisc and Monovisc; its multi- and single-injection treatments for osteoarthritis of the knee, to surgical aids in the ophthalmic and anti-adhesion fields. The company was founded in 1983 and is headquartered in Bedford, Massachusetts.
Latest Quarter Results
Anika's total revenue for the fourth quarter of 2014 was $23.3 million, compared with $21.3 million in the fourth quarter of 2013. For the full-year 2014, total revenue grew 41% to $105.6 million from $75.1 million a year earlier. Product revenue increased to $75.5 million in 2014 from $71.8 million in 2013.
Net income for the fourth quarter was up 17% to $7.8 million, or $0.51 per diluted share, from $6.7 million, or $0.44 per diluted share, in the year-earlier quarter. For full-year 2014, net income increased 86% to $38.3 million, or $2.51 per diluted share, from $20.6 million, or $1.39 per diluted share, in 2013.
In the company's earnings statement, Charles H. Sherwood, Ph.D., President and Chief Executive Officer said:
We achieved several key business milestones that position the Company well for continued success into the future. The exceptional clinical, regulatory and commercial milestones we accomplished in 2014 have set the stage for solid financial results in 2015 and accelerated profitable growth in future years.
Growth
Anika has recorded substantial growth in the last few years. The company's annual average sales growth over the last five years was at 21.4%, and the average EPS growth was extremely high at 51%. The estimated EPS growth for the next year is at 17.65%, and the average annual estimated EPS growth for the next five years is exceptionally high at 30%.
(click to enlarge)
Source: Fourth Quarter 2014 Investor Conference Call
In addition, ANIK's growth rates parameters have been much better than its industry median, its sector median and the S&P 500 median as shown in the table below.
(click to enlarge)
Source: Portfolio123
Valuation
ANIK's stock has underperformed the market in the last year. Since the beginning of 2014, ANIK's stock has gained only 4.2%, while the S&P 500 index has increased 11.1%, and the Nasdaq Composite Index has risen 16.6%. However, ANIK was a big winner in 2013, gaining an astounding 283.9% in the year, while the S&P 500 index has increased 29.6%, and the Nasdaq Composite Index has risen 38.3% in that year.
(click to enlarge)
Chart: TradeStation Group, Inc.
ANIK's valuation metrics are excellent, the company has no debt at all, and its quick ratio is extremely high at 21.1. Furthermore, its enterprise value/EBITDA ratio is very low at 7.32, and its PEG ratio is exceptionally low at 0.53.
In addition, ANIK's margins parameters have been much better than its industry median, its sector median and the S&P 500 median as shown in the table below.
(click to enlarge)
Source: Portfolio123
Looking Forward
Anika's development pipeline is strong with an increased focus on regenerative medicine and product concepts that have the potential to expand its market opportunities dramatically. The company has two new products, Cingal and Hyalofast advancing toward full commercialization. Its Phase III trial for Hyalofast is scheduled to begin this year and with CE mark approval for Cingal likely in hand by year end, Anika is turning its attention to commercialization and the potential for revenue from Cingal beginning within the next 18 months. In addition, Anika continues to develop patent applications and receive patent approvals based primarily on the HYAFF technology that it acquired with its Italian subsidiary Anika S.r.l. The company was awarded five such patents in 2014. One of them, for example, is directed to meniscus repair and regeneration while another was for spinal anti-adhesion application. According to the company, its prospects have never been brighter as it begins 2015.
Summary
Anika's development pipeline is strong with an increased focus on regenerative medicine and product concepts that have the potential to expand its market opportunities dramatically. The company has recorded substantial growth in the last few years, and its future growth prospects are extremely high. Moreover, Anika has compelling valuation metrics; its enterprise value/EBITDA ratio is very low at 7.32, and its PEG ratio is exceptionally low at 0.53. In my opinion, ANIK's stock has plenty of room to grow, and it is a Buy right now.
Source: A Growth Strategy With Extraordinary Results: A Look At Anika Therapeutics
Disclosure: The author is long ANIK, AGO, DEPO, JNS, JOE,NDAQ, RE, REX, UVE, WDR. (More...)The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.
Share this article with a colleague
30.07.15 09:44
#10
TasTea
2.Q. Umsatz und Gewinn zieht wieder an
Expansion und neue Produkte entwickeln sich sehr gut. Mitteilung zum 2.Q; eps $ 0,51
Anika Therapeutics
Anika Therapeutics Delivers Solid Second Quarter 2015 Financial Results and Continued Pipeline Progress
Strength in Quarter Driven by Continued Adoption of Orthobiologics Products;
Combined ORTHOVISC® and MONOVISC® U.S. Market Share Surpasses 25%
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic acid (HA) technology, today reported financial results for the second quarter ended June 30, 2015, along with business progress in the period.
"The solid results we delivered in the second quarter demonstrate accelerating demand, which combined with our tangible pipeline progress, positions Anika to deliver robust growth for many years," stated Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "As in recent quarters, physician and patient demand for our homegrown orthobiologics products continued to gain traction, and was the highlight of our commercial results. We expect that trend to continue with the launch of two important orthopedic products in the coming years, which will provide an important catalyst for additional value creation."
Second Quarter Financial Results
Product revenue was up 8 percent in 2015.
At the end of the quarter, ORTHOVISC and MONOVISC achieved a combined 26 percent share of the U.S. viscosupplementation market. ORTHOVISC continues to grow and is maintaining its market-leading position in the multi-injection segment. MONOVISC experienced accelerated growth, and now holds the number two position in the single-injection segment.
Total revenue for the second quarter of 2015 was $22.9 million. In last year's second quarter, the Company reported $5 million in milestone revenue from the first commercial sale of MONOVISC in the U.S., resulting in total revenue of $26.3 million.
Total operating expenses for the second quarter of 2015 were $10.5 million compared with $11.1 million in the second quarter of 2014. The decrease was primarily driven by lower SG&A expenses as a result of the full amortization of certain intangible assets at the end of 2014.
Net income for the second quarter was $7.8 million, or $0.51 per diluted share, compared with $9.3 million, or $0.60 per diluted share, for the second quarter of 2014. Last year's results included $5 million in milestone revenue as a result of the first commercial sale of MONOVISC in the U.S. Excluding the impact of this milestone revenue, net income and diluted EPS increased $1.6 million, and $0.11, respectively.
Recent Business Highlights
The Company continues to make solid headway in expanding the commercial reach of existing products and advancing the progress of products in its development pipeline. Recent highlights of the business include:
Agreements with new partners in India and Australia for the commercialization of MONOVISC.
Submission and approval of an investigational device exemption (IDE) to evaluate the utility of MONOVISC, the Company's single-injection product, in treating hip pain associated with osteoarthritis. The study is sponsored by Anika's exclusive U.S. commercial partner for MONOVISC, and is expected to commence patient enrollment in the U.S. before the end of this year.
Positive results from a 242-patient study evaluating the safety of a repeat injection of CINGAL, the first viscosupplement to combine the HA formulation found in MONOVISC with a steroid into a single injection to treat pain and reduce inflammation caused by osteoarthritis. The results of this follow-up study combined with the initial Phase 3 data suggest that CINGAL retains an excellent safety profile as an initial injection as well as a repeat injection. CINGAL is currently progressing through the regulatory process in the U.S., Europe, and Canada.
Approval of a HYALOFAST IDE by the U.S. FDA. HYALOFAST, a biodegradable 3D scaffold that enables cartilage regeneration, has been used in more than 6,000 patients outside of the U.S. via a non-invasive, single-step arthroscopic procedure. HYALOFAST is commercially available in 18 countries. With approval of this IDE, the Company is on track to commence patient enrollment at sites in the United States and Europe beginning in the fourth quarter of 2015.
During the quarter, Anika further established its commitment to developing the next generation of orthopedic medicine, announcing a multiyear research collaboration with the University of Massachusetts (UMass) Amherst to develop a novel treatment for rheumatoid arthritis (RA). This partnership combines Anika's proprietary HA technology with UMass Amherst's preclinical research and scientific expertise with the goal to develop the first localized therapy for RA that is cost-effective and can have a systemic impact on a large patient population with currently limited treatment options.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its financial results, business highlights and financial outlook tomorrow, Thursday, July 30th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures, and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products range from orthopedic/joint health solutions led by ORTHOVISC and MONOVISC, treatments for osteoarthritis, to surgical aids in the anti-adhesion and ophthalmic fields. The Company also offers aesthetic dermal fillers for the correction of facial wrinkles. Anika's Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA products in orthopedic/joint health and anti-adhesion, as well as therapeutics in areas such as advanced wound treatment and ear, nose and throat care. Its regenerative technology advances Anika's vision to offer therapeutic products and medical solutions that go beyond pain relief to protect and restore damaged tissue.
Forward-Looking Statements
The statements made in the second paragraph of this press release, as well as the second and fourth bullet points and final paragraph of the section captioned "Recent Business Highlights," which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the company's product pipeline and growth opportunities, the enrollment of patients in the Company's clinical studies, and the objective of the Company's partnership with UMass Amherst. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company's ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST or for expanded indications of the Company's MONOVISC product, on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations and production planning; (vi) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; (x) the Company's ability to continue to successfully manage Anika Therapeutics S.r.l.'s business; and (xi) the Company's ability to achieve its growth targets.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(unaudited)
§ Three Months Ended June 30, Six Months Ended June 30,
§ 2015 2014 2015 2014
Product revenue $ 22,898,032 $ 21,267,156 $ 38,412,714 $ 35,618,561
Licensing, milestone and contract revenue 5,529 5,007,504 11,171 24,666,386
Total revenue 22,903,561 26,274,660 38,423,885 60,284,947
§
Operating expenses:
Cost of product revenue 5,274,059 5,332,913 9,587,499 9,693,932
Research & development 1,812,320 1,873,158 3,910,082 4,160,873
Selling, general & administrative 3,388,494 3,865,876 6,993,155 7,356,861
Total operating expenses 10,474,873 11,071,947 20,490,736 21,211,666
Income from operations 12,428,688 15,202,713 17,933,149 39,073,281
Interest income, net 23,907 5,935 47,630 6,402
Income before income taxes 12,452,595 15,208,648 17,980,779 39,079,683
Provision for income taxes 4,633,038 5,906,298 6,645,665 14,747,080
Net income $ 7,819,557 $ 9,302,350 $ 11,335,114 $ 24,332,603
§
Basic net income per share:
Net income $ 0.52 $ 0.63 $ 0.76 $ 1.67
Basic weighted average common shares outstanding 14,961,436 14,687,747 14,933,534 14,559,917
Diluted net income per share:
Net income $ 0.51 $ 0.60 $ 0.74 $ 1.57
Diluted weighted average common shares outstanding 15,335,687 15,492,732 15,332,391 15,487,432
§
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
§ June 30, December 31,
ASSETS 2015 2014
Current assets:
Cash and cash equivalents $ 103,920,222 $ 100,155,864
Investments 18,513,150 6,750,000
Accounts receivable, net of reserves of $133,820 and $146,618 at June 30, 2015 and December 31,2014, respectively 19,166,116 17,152,028
Inventories 11,718,243 12,406,776
Prepaid income taxes - 412,301
Current portion deferred income taxes 1,459,867 1,188,768
Prepaid expenses and other 947,939 959,305
Total current assets 155,725,537 139,025,042
Property and equipment, at cost 54,671,505 53,619,589
Less: accumulated depreciation (23,148,636 ) (21,950,706 )
§31,522,869 31,668,883
Long-term deposits and other 69,016 69,042
Intangible assets, net 13,083,907 14,894,710
Goodwill 7,610,821 8,338,699
Total Assets $ 208,012,150 $ 193,996,376
§
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,657,683 $ 1,201,226
Accrued expenses 4,441,785 4,747,526
Deferred revenue 35,938 24,510
Income taxes payable 1,821,898 -
Total current liabilities 7,957,304 5,973,262
Other long-term liabilities 779,666 893,935
Long-term deferred revenue 74,371 102,192
Deferred tax liability 8,633,398 8,929,890
Commitments and contingencies - -
Stockholders' equity:
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively - -
Common stock, $.01 par value; 30,000,000 shares authorized, 15,003,694 and 14,851,703 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively 150,037 148,517
Additional paid-in-capital 80,505,021 77,539,699
Accumulated other comprehensive loss (6,326,442 ) (4,494,800 )
Retained earnings 116,238,795 104,903,681
Total stockholders' equity 190,567,411 178,097,097
Total Liabilities and Stockholders' Equity $ 208,012,150 $ 193,996,376
§
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
§
§
Revenue by Product Line and Product Gross Margin
(unaudited)
§
§Quarter Ended June 30, 6 Months Ended June 30,
§ 2015 % 2014 % 2015 % 2014 %
Orthobiologics $ 19,282,919 84% $ 18,278,254 86% $ 31,255,419 81% $ 29,850,404 84%
Dermal 303,117 1% 348,961 2% 719,300 2% 537,612 1%
Surgical 1,647,005 7% 1,376,530 6% 3,036,600 8% 3,128,549 9%
Ophthalmic 414,991 2% 363,411 2% 919,463 2% 571,996 2%
Veterinary 1,250,000 6% 900,000 4% 2,481,932 7% 1,530,000 4%
Total Product Revenue $ 22,898,032 100% $ 21,267,156 100% $ 38,412,714 100% $ 35,618,561 100%
§
§
Product gross profit $ 17,623,973 $ 15,934,243 $ 28,825,215 $ 25,924,629
Product gross margin 77% 75% 75% 73%
§
§
Total Product Revenue by Geographic Region
(unaudited)
§
§Quarter Ended June 30, 6 Months Ended June 30,
§ 2015 % 2014 % 2015 %
§2014 %
Geographic Location:
§
United States $ 19,217,696 84% $ 17,946,738 85% $ 31,808,886 83% $ 29,827,778 84%
Europe 2,330,890 10% 1,789,766 8% 4,317,214 11% 3,482,903 10%
Other 1,349,446 6% 1,530,652 7% 2,286,614 6% 2,307,880 6%
Total Revenue $ 22,898,032 100% $ 21,267,156 100% $ 38,412,714 100% $ 35,618,561 100%
View source version on businesswire.com: http://www.businesswire.com/news/home/20150729006660/en/
Anika Therapeutics, Inc.
Christopher Ranjitkar, 781-457-9000
IR & Corporate Communications Manager
Source: Anika Therapeutics, Inc.
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Anika Therapeutics
32 Wiggins Ave , Bedford, MA 01730
Service provided by Shareholder.com
Anika Therapeutics
Anika Therapeutics Delivers Solid Second Quarter 2015 Financial Results and Continued Pipeline Progress
Strength in Quarter Driven by Continued Adoption of Orthobiologics Products;
Combined ORTHOVISC® and MONOVISC® U.S. Market Share Surpasses 25%
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic acid (HA) technology, today reported financial results for the second quarter ended June 30, 2015, along with business progress in the period.
"The solid results we delivered in the second quarter demonstrate accelerating demand, which combined with our tangible pipeline progress, positions Anika to deliver robust growth for many years," stated Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "As in recent quarters, physician and patient demand for our homegrown orthobiologics products continued to gain traction, and was the highlight of our commercial results. We expect that trend to continue with the launch of two important orthopedic products in the coming years, which will provide an important catalyst for additional value creation."
Second Quarter Financial Results
Product revenue was up 8 percent in 2015.
At the end of the quarter, ORTHOVISC and MONOVISC achieved a combined 26 percent share of the U.S. viscosupplementation market. ORTHOVISC continues to grow and is maintaining its market-leading position in the multi-injection segment. MONOVISC experienced accelerated growth, and now holds the number two position in the single-injection segment.
Total revenue for the second quarter of 2015 was $22.9 million. In last year's second quarter, the Company reported $5 million in milestone revenue from the first commercial sale of MONOVISC in the U.S., resulting in total revenue of $26.3 million.
Total operating expenses for the second quarter of 2015 were $10.5 million compared with $11.1 million in the second quarter of 2014. The decrease was primarily driven by lower SG&A expenses as a result of the full amortization of certain intangible assets at the end of 2014.
Net income for the second quarter was $7.8 million, or $0.51 per diluted share, compared with $9.3 million, or $0.60 per diluted share, for the second quarter of 2014. Last year's results included $5 million in milestone revenue as a result of the first commercial sale of MONOVISC in the U.S. Excluding the impact of this milestone revenue, net income and diluted EPS increased $1.6 million, and $0.11, respectively.
Recent Business Highlights
The Company continues to make solid headway in expanding the commercial reach of existing products and advancing the progress of products in its development pipeline. Recent highlights of the business include:
Agreements with new partners in India and Australia for the commercialization of MONOVISC.
Submission and approval of an investigational device exemption (IDE) to evaluate the utility of MONOVISC, the Company's single-injection product, in treating hip pain associated with osteoarthritis. The study is sponsored by Anika's exclusive U.S. commercial partner for MONOVISC, and is expected to commence patient enrollment in the U.S. before the end of this year.
Positive results from a 242-patient study evaluating the safety of a repeat injection of CINGAL, the first viscosupplement to combine the HA formulation found in MONOVISC with a steroid into a single injection to treat pain and reduce inflammation caused by osteoarthritis. The results of this follow-up study combined with the initial Phase 3 data suggest that CINGAL retains an excellent safety profile as an initial injection as well as a repeat injection. CINGAL is currently progressing through the regulatory process in the U.S., Europe, and Canada.
Approval of a HYALOFAST IDE by the U.S. FDA. HYALOFAST, a biodegradable 3D scaffold that enables cartilage regeneration, has been used in more than 6,000 patients outside of the U.S. via a non-invasive, single-step arthroscopic procedure. HYALOFAST is commercially available in 18 countries. With approval of this IDE, the Company is on track to commence patient enrollment at sites in the United States and Europe beginning in the fourth quarter of 2015.
During the quarter, Anika further established its commitment to developing the next generation of orthopedic medicine, announcing a multiyear research collaboration with the University of Massachusetts (UMass) Amherst to develop a novel treatment for rheumatoid arthritis (RA). This partnership combines Anika's proprietary HA technology with UMass Amherst's preclinical research and scientific expertise with the goal to develop the first localized therapy for RA that is cost-effective and can have a systemic impact on a large patient population with currently limited treatment options.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its financial results, business highlights and financial outlook tomorrow, Thursday, July 30th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures, and commercializes therapeutic products for tissue protection, healing, and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products range from orthopedic/joint health solutions led by ORTHOVISC and MONOVISC, treatments for osteoarthritis, to surgical aids in the anti-adhesion and ophthalmic fields. The Company also offers aesthetic dermal fillers for the correction of facial wrinkles. Anika's Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA products in orthopedic/joint health and anti-adhesion, as well as therapeutics in areas such as advanced wound treatment and ear, nose and throat care. Its regenerative technology advances Anika's vision to offer therapeutic products and medical solutions that go beyond pain relief to protect and restore damaged tissue.
Forward-Looking Statements
The statements made in the second paragraph of this press release, as well as the second and fourth bullet points and final paragraph of the section captioned "Recent Business Highlights," which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the company's product pipeline and growth opportunities, the enrollment of patients in the Company's clinical studies, and the objective of the Company's partnership with UMass Amherst. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company's ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST or for expanded indications of the Company's MONOVISC product, on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations and production planning; (vi) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; (x) the Company's ability to continue to successfully manage Anika Therapeutics S.r.l.'s business; and (xi) the Company's ability to achieve its growth targets.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(unaudited)
§ Three Months Ended June 30, Six Months Ended June 30,
§ 2015 2014 2015 2014
Product revenue $ 22,898,032 $ 21,267,156 $ 38,412,714 $ 35,618,561
Licensing, milestone and contract revenue 5,529 5,007,504 11,171 24,666,386
Total revenue 22,903,561 26,274,660 38,423,885 60,284,947
§
Operating expenses:
Cost of product revenue 5,274,059 5,332,913 9,587,499 9,693,932
Research & development 1,812,320 1,873,158 3,910,082 4,160,873
Selling, general & administrative 3,388,494 3,865,876 6,993,155 7,356,861
Total operating expenses 10,474,873 11,071,947 20,490,736 21,211,666
Income from operations 12,428,688 15,202,713 17,933,149 39,073,281
Interest income, net 23,907 5,935 47,630 6,402
Income before income taxes 12,452,595 15,208,648 17,980,779 39,079,683
Provision for income taxes 4,633,038 5,906,298 6,645,665 14,747,080
Net income $ 7,819,557 $ 9,302,350 $ 11,335,114 $ 24,332,603
§
Basic net income per share:
Net income $ 0.52 $ 0.63 $ 0.76 $ 1.67
Basic weighted average common shares outstanding 14,961,436 14,687,747 14,933,534 14,559,917
Diluted net income per share:
Net income $ 0.51 $ 0.60 $ 0.74 $ 1.57
Diluted weighted average common shares outstanding 15,335,687 15,492,732 15,332,391 15,487,432
§
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
§ June 30, December 31,
ASSETS 2015 2014
Current assets:
Cash and cash equivalents $ 103,920,222 $ 100,155,864
Investments 18,513,150 6,750,000
Accounts receivable, net of reserves of $133,820 and $146,618 at June 30, 2015 and December 31,2014, respectively 19,166,116 17,152,028
Inventories 11,718,243 12,406,776
Prepaid income taxes - 412,301
Current portion deferred income taxes 1,459,867 1,188,768
Prepaid expenses and other 947,939 959,305
Total current assets 155,725,537 139,025,042
Property and equipment, at cost 54,671,505 53,619,589
Less: accumulated depreciation (23,148,636 ) (21,950,706 )
§31,522,869 31,668,883
Long-term deposits and other 69,016 69,042
Intangible assets, net 13,083,907 14,894,710
Goodwill 7,610,821 8,338,699
Total Assets $ 208,012,150 $ 193,996,376
§
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,657,683 $ 1,201,226
Accrued expenses 4,441,785 4,747,526
Deferred revenue 35,938 24,510
Income taxes payable 1,821,898 -
Total current liabilities 7,957,304 5,973,262
Other long-term liabilities 779,666 893,935
Long-term deferred revenue 74,371 102,192
Deferred tax liability 8,633,398 8,929,890
Commitments and contingencies - -
Stockholders' equity:
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively - -
Common stock, $.01 par value; 30,000,000 shares authorized, 15,003,694 and 14,851,703 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively 150,037 148,517
Additional paid-in-capital 80,505,021 77,539,699
Accumulated other comprehensive loss (6,326,442 ) (4,494,800 )
Retained earnings 116,238,795 104,903,681
Total stockholders' equity 190,567,411 178,097,097
Total Liabilities and Stockholders' Equity $ 208,012,150 $ 193,996,376
§
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
§
§
Revenue by Product Line and Product Gross Margin
(unaudited)
§
§Quarter Ended June 30, 6 Months Ended June 30,
§ 2015 % 2014 % 2015 % 2014 %
Orthobiologics $ 19,282,919 84% $ 18,278,254 86% $ 31,255,419 81% $ 29,850,404 84%
Dermal 303,117 1% 348,961 2% 719,300 2% 537,612 1%
Surgical 1,647,005 7% 1,376,530 6% 3,036,600 8% 3,128,549 9%
Ophthalmic 414,991 2% 363,411 2% 919,463 2% 571,996 2%
Veterinary 1,250,000 6% 900,000 4% 2,481,932 7% 1,530,000 4%
Total Product Revenue $ 22,898,032 100% $ 21,267,156 100% $ 38,412,714 100% $ 35,618,561 100%
§
§
Product gross profit $ 17,623,973 $ 15,934,243 $ 28,825,215 $ 25,924,629
Product gross margin 77% 75% 75% 73%
§
§
Total Product Revenue by Geographic Region
(unaudited)
§
§Quarter Ended June 30, 6 Months Ended June 30,
§ 2015 % 2014 % 2015 %
§2014 %
Geographic Location:
§
United States $ 19,217,696 84% $ 17,946,738 85% $ 31,808,886 83% $ 29,827,778 84%
Europe 2,330,890 10% 1,789,766 8% 4,317,214 11% 3,482,903 10%
Other 1,349,446 6% 1,530,652 7% 2,286,614 6% 2,307,880 6%
Total Revenue $ 22,898,032 100% $ 21,267,156 100% $ 38,412,714 100% $ 35,618,561 100%
View source version on businesswire.com: http://www.businesswire.com/news/home/20150729006660/en/
Anika Therapeutics, Inc.
Christopher Ranjitkar, 781-457-9000
IR & Corporate Communications Manager
Source: Anika Therapeutics, Inc.
You are subscribed to Anika Therapeutics Investor Relations' e-mail alerts as monika@bergbauer-ladenbau.de.
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Anika Therapeutics
32 Wiggins Ave , Bedford, MA 01730
Service provided by Shareholder.com
29.10.15 09:24
#11
TasTea
Zahlen zum 3.Q
eps im 3. Q steigt auf 0,55 $, Analystenerwartungen wurden damit weit geschlagen (waren 0,34$)
der Marktanteil von Orthovisc und Monovisc in Amerika steigt auf 27%;
mit dem weiter wachsenden Markt, der Expansion, und neuer Produktzulassungen 2016 erwarte ich ein stetiges langfristiges Wachstum;
Bericht siehe auch Homepage Anika Therapeutics.
Anika Therapeutics Reports Robust Financial Performance and Continued Progress on Key Fronts in Third Quarter of 2015
Company Achieves 37.5% Year-over-Year Diluted EPS Growth in Quarter
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today reported financial results for the third quarter ended September 30, 2015, along with business progress in the period.
"Our third quarter sales and profits were driven by strength in end-user demand, which together with continuing pipeline progress, provides a robust foundation for future growth," stated Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "Our viscosupplementation portfolio, anchored by ORTHOVISC® and MONOVISC®, continues to grow and is poised to take and hold greater leadership in the market. We believe this strong positioning, along with our steady pipeline progress during the quarter, sets our company up to deliver financial results and shareholder value for the long term."
Third Quarter Financial Results
Product revenue grew 8% in the third quarter of 2015.
ORTHOVISC and MONOVISC continued to command a strong position in the market, with a combined share that grew modestly to 27% of the U.S. viscosupplementation market at the end of the third quarter. ORTHOVISC continues to maintain its market-leading position in the multi-injection segment. MONOVISC holds the number two position in the single-injection segment.
Total revenue for the third quarter of 2015 was $23.7 million, compared with $22.1 million in the third quarter of 2014. The increase was primarily driven by the continued growth in MONOVISC adoption in the U.S.
Total operating expenses for the third quarter of 2015 were $10.5 million, compared with $11.8 million in the third quarter of 2014. The decrease was primarily driven by lower cost of goods sold as a result of favorable revenue mix, the full amortization of certain intangible assets at the end of 2014, and certain employee termination-related expenses in the third quarter of 2014.
Net income for the third quarter was $8.4 million, or $0.55 per diluted share, compared with $6.2 million, or $0.40 per diluted share, for the third quarter of 2014.
Recent Business Highlights
During the quarter, the Company continued making pipeline and operational progress, including, as follows:
A formal meeting with the FDA's Office of Combination Products to discuss a planned application to request a device designation for CINGAL, followed by a formal written request for designation. A decision from the FDA is expected by the end of the year.
The buildout of additional manufacturing space in, and the movement of the Company's Italian manufacturing facilities to, Anika's Bedford, Mass. global headquarters. This initiative is intended to consolidate production for all the Company's products, and to accelerate product development.
The signing of a lease agreement by Anika's wholly-owned Italian subsidiary, Anika Therapeutics S.r.l., to build office space in Padova, Italy to serve as Anika's European headquarters. This site will serve as Anika's European hub for sales, marketing, and distribution and will also house administrative and product development operations, and is intended to provide the Company with infrastructure to support future growth.
der Marktanteil von Orthovisc und Monovisc in Amerika steigt auf 27%;
mit dem weiter wachsenden Markt, der Expansion, und neuer Produktzulassungen 2016 erwarte ich ein stetiges langfristiges Wachstum;
Bericht siehe auch Homepage Anika Therapeutics.
Anika Therapeutics Reports Robust Financial Performance and Continued Progress on Key Fronts in Third Quarter of 2015
Company Achieves 37.5% Year-over-Year Diluted EPS Growth in Quarter
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today reported financial results for the third quarter ended September 30, 2015, along with business progress in the period.
"Our third quarter sales and profits were driven by strength in end-user demand, which together with continuing pipeline progress, provides a robust foundation for future growth," stated Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "Our viscosupplementation portfolio, anchored by ORTHOVISC® and MONOVISC®, continues to grow and is poised to take and hold greater leadership in the market. We believe this strong positioning, along with our steady pipeline progress during the quarter, sets our company up to deliver financial results and shareholder value for the long term."
Third Quarter Financial Results
Product revenue grew 8% in the third quarter of 2015.
ORTHOVISC and MONOVISC continued to command a strong position in the market, with a combined share that grew modestly to 27% of the U.S. viscosupplementation market at the end of the third quarter. ORTHOVISC continues to maintain its market-leading position in the multi-injection segment. MONOVISC holds the number two position in the single-injection segment.
Total revenue for the third quarter of 2015 was $23.7 million, compared with $22.1 million in the third quarter of 2014. The increase was primarily driven by the continued growth in MONOVISC adoption in the U.S.
Total operating expenses for the third quarter of 2015 were $10.5 million, compared with $11.8 million in the third quarter of 2014. The decrease was primarily driven by lower cost of goods sold as a result of favorable revenue mix, the full amortization of certain intangible assets at the end of 2014, and certain employee termination-related expenses in the third quarter of 2014.
Net income for the third quarter was $8.4 million, or $0.55 per diluted share, compared with $6.2 million, or $0.40 per diluted share, for the third quarter of 2014.
Recent Business Highlights
During the quarter, the Company continued making pipeline and operational progress, including, as follows:
A formal meeting with the FDA's Office of Combination Products to discuss a planned application to request a device designation for CINGAL, followed by a formal written request for designation. A decision from the FDA is expected by the end of the year.
The buildout of additional manufacturing space in, and the movement of the Company's Italian manufacturing facilities to, Anika's Bedford, Mass. global headquarters. This initiative is intended to consolidate production for all the Company's products, and to accelerate product development.
The signing of a lease agreement by Anika's wholly-owned Italian subsidiary, Anika Therapeutics S.r.l., to build office space in Padova, Italy to serve as Anika's European headquarters. This site will serve as Anika's European hub for sales, marketing, and distribution and will also house administrative and product development operations, and is intended to provide the Company with infrastructure to support future growth.
29.02.16 15:34
#12
TasTea
Zahlen Q4
Anika Therapeutics Delivers Strong Performance with Record Product Revenue for the Fourth Quarter and Full Year 2015
Product Revenue Increased 43% Year-over-Year for Fourth Quarter of 2015
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today reported financial results for the fourth quarter and full year ended December 31, 2015, along with business progress in the periods.
"We ended 2015 and entered 2016 with strong momentum in all aspects of our business -- commercial, clinical, operational, and financial," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "First, product revenue increased 43% year-over-year for the fourth quarter, and our viscosupplementation franchise delivered robust performance and remained on track for market leadership in 2017. Second, we continued to advance our late-stage HA-based pipeline candidates, CINGAL and HYALOFAST, through the clinical development and regulatory channels. Third, as part of our strategic shift towards direct commercialization, we are consolidating our global manufacturing operations at our U.S. headquarters. Finally, we renewed our interest in strategic M&A opportunities that could augment our thriving organic business, and create value for shareholders over the short and long terms."
Fourth Quarter and Full Year Financial Results
Product revenue grew 43% year-over-year for the fourth quarter of 2015, and 16% for the full year of 2015. The Company saw normal inventory purchase growth patterns resume in the fourth quarter after the conclusion of an inventory rebalancing by its U.S. commercial partner.
Total revenue for the fourth quarter of 2015 increased 33% to $30.9 million, compared to $23.3 million for the fourth quarter of 2014. The increase was primarily driven by the continued growth in Anika's viscosupplementation franchise worldwide. Total revenue for the full year of 2015 was $93.0 million, compared to $105.6 million for the full year of 2014. The decline was due to the receipt of $30 million of licensing, milestone and contract revenue related to MONOVISC product approval, launch, and achievement of a unique CMS reimbursement code in 2014, which was partially offset by $5 million of milestone revenue received in 2015 for the achievement of a target MONOVISC U.S. end user sales threshold.
ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment. Overall, there was a 24% increase in the combined U.S. viscosupplementation end-user revenue in 2015, with MONOVISC end-user sales more than tripling year-over-year domestically.
The Company received a $5.0 million milestone payment in the fourth quarter of 2015 from its U.S. commercial partner as a result of MONOVISC achieving $50 million in end-user revenue in 2015.
Net income for the fourth quarter of 2015 increased 41% to $11.0 million, or $0.72 per diluted share, compared to $7.8 million, or $0.51 per diluted share, for the fourth quarter of 2014. Net income for the full year of 2015 was $30.8 million, or $2.01 per diluted share, compared to $38.3 million, or $2.51 per diluted share. Full-year 2014 results reflected the favorable impact of the $30 million of licensing, milestone and contract revenue previously discussed.
Recent Business Highlights
The Company made key pipeline, commercial, operational, and financial advancements, including:
The commencement of patient enrollment in the Company's HYALOFAST FastTRACK study. HYALOFAST, a biodegradable scaffold, is used to enable cartilage regeneration in patients suffering from cartilage defects. The FastTRACK study is a prospective, randomized, active treatment-controlled, multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. It will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. We believe HYALOFAST is poised to take a market leadership position.
The decision to pursue CINGAL approval in the U.S. through the New Drug Application pathway, and the approval of CINGAL by Health Canada for the treatment of pain associated with osteoarthritis of the knee.
An agreement with a new commercial partner in China for the commercialization of both MONOVISC and CINGAL.
Ongoing progress with full integration of the Company's global manufacturing operations under one roof in Anika's Bedford, Mass. global headquarters. This integration is intended to accelerate product development and to enable full control of the Company's supply chain.
Full Year 2016 Corporate Outlook
Looking forward to 2016, the Company expects total revenue growth to be in the mid-teen percentage range. The Company also anticipates continued headway on several key initiatives including:
Resolution of open items for the submission of CINGAL New Drug Application.
Approval of CINGAL in the E.U. and launch of CINGAL in Canada and Europe.
Advancement toward full patient enrollment in the Company's HYALOFAST FastTRACK study.
Integration of global manufacturing operations in Anika's Bedford, Mass. global headquarters.
Initial occupation of the Company's new Padua, Italy office, which will serve as its new European hub.
Progress in the development of a direct commercialization capability in the U.S.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its financial results, business highlights and financial outlook tomorrow, Thursday, February 25th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the second paragraph, the first and fourth bullet points in the section captioned "Recent Business Highlights," and the section captioned "Full Year 2016 Corporate Outlook" of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company's direct commercialization capabilities, the Company's interest in strategic M&A transactions, enrollment rates in the HYALOFAST clinical study, the commercial potential of HYALOFAST, the integration of the Company's manufacturing operations, the approval of CINGAL in the European Union, and the Company's expected revenue growth. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company's ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST, on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products, including for CINGAL; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
§
§Three Months Ended December 31, Year Ended December 31,
§ 2015 2014 2015 2014
Product revenue $
25,607
§$ 17,880 $ 87,696 $ 75,474
Licensing, milestone and contract revenue
5,287
§
5,375
§ 5,303 30,121
Total revenue 30,894
23,255
§92,999 105,595
§
Operating expenses:
Cost of product revenue 6,290
5,511
§21,053 20,930
Research & development 3,016
1,984
§8,987 8,144
Selling, general & administrative
4,524
§
3,673
§ 14,825 15,074
Total operating expenses
13,830
§
11,168
§ 44,865 44,148
Income from operations
17,064
§12,087 48,134 61,447
Interest income, net 39 42 120 58
Income before income taxes
17,103
§12,129 48,254 61,505
Provision for income taxes 6,061 4,313 17,496 23,186
Net income $
11,042
§$ 7,816 $ 30,758 $ 38,319
§
Basic net income per share:
Net income $ 0.74 $ 0.53 $ 2.06 $ 2.61
Basic weighted average common shares outstanding 14,965 14,801 14,934 14,678
Diluted net income per share:
Net income $ 0.72 $ 0.51 $ 2.01 $ 2.51
Diluted weighted average common shares outstanding 15,353 15,278 15,321 15,269
§
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
§
§December 31, December 31,
ASSETS 2015 2014
Current assets:
Cash and cash equivalents $ 110,707
§$ 100,156
Investments 27,751 6,750
Accounts receivable, net of reserves of $167 and $147 at December 31, 2015 and 2014, respectively 21,652 17,152
Inventories 14,938 12,407
Prepaid expenses and other current assets 1,385 1,371
Total current assets 176,433 137,836
Property and equipment, at cost 64,648 53,620
Less: accumulated depreciation (24,540 ) (21,951 )
§40,108 31,669
Long-term deposits and other 69 69
Intangible assets, net 11,656 14,895
Goodwill 7,482 8,339
Total Assets $ 235,748 $ 192,808
§
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 8,302 $ 1,201
Accrued expenses and other current liabilities
§4,778 4,772
Income taxes payable 4,198 -
Total current liabilities 17,278 5,973
Other long-term liabilities 781 894
Long-term deferred revenue 66 102
Deferred tax liability 6,775 7,741
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at December 31, 2015 and December 31, 2014 - -
Common stock, $.01 par value; 30,000,000 shares authorized, 15,036,808 and 14,851,703 shares issued and outstanding at December 31, 2015 and 2014, respectively 150 149
Additional paid-in-capital 81,685 77,540
Accumulated other comprehensive loss (6,649 ) (4,495 )
Retained earnings 135,662 104,904
Total stockholders' equity 210,848 178,098
Total Liabilities and Stockholders' Equity $ 235,748 $ 192,808
§
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
§
§
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
§
§Quarter Ended December 31, Year Ended December 31,
§ 2015 % 2014 % 2015 % 2014 %
Orthobiologics $ 21,530 84 % $ 13,207 74 % $ 73,247 84 % $ 61,957 82 %
Surgical 1,363 5 % 1,273 7 % 5,812 7 % 5,855 8 %
Dermal 1,134 5 % 395 2 % 2,266 2 % 1,334 2 %
Other
1,580
§ 6 % 3,005 17 % 6,371 7 % 6,328 8 %
Total Product Revenue $
25,607
§ 100 % $ 17,880 100 % $ 87,696 100 % $ 75,474 100 %
§
Product Gross Profit
§$
19,317
§$
12,369
§$ 66,643 $ 54,544
Product Gross Margin
75§
§% 69 % 76 % 72 %
§
§
Total Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
§
§Quarter Ended December 31, Year Ended December 31,
§ 2015 % 2014 % 2015 % 2014 %
Geographic Location:
§
United States $ 20,574 80 % $ 14,324 80 % $ 71,621 82 % $ 62,606 83 %
Europe 2,462 10 % 936 5 % 8,756 10 % 6,204 8 %
Other
2,571
§ 10 % 2,620 15 % 7,319 8 % 6,664 9 %
Total Revenue $
25,607
§ 100 % $ 17,880 100 % $ 87,696 100 % $ 75,474 100 %
Product Revenue Increased 43% Year-over-Year for Fourth Quarter of 2015
BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today reported financial results for the fourth quarter and full year ended December 31, 2015, along with business progress in the periods.
"We ended 2015 and entered 2016 with strong momentum in all aspects of our business -- commercial, clinical, operational, and financial," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "First, product revenue increased 43% year-over-year for the fourth quarter, and our viscosupplementation franchise delivered robust performance and remained on track for market leadership in 2017. Second, we continued to advance our late-stage HA-based pipeline candidates, CINGAL and HYALOFAST, through the clinical development and regulatory channels. Third, as part of our strategic shift towards direct commercialization, we are consolidating our global manufacturing operations at our U.S. headquarters. Finally, we renewed our interest in strategic M&A opportunities that could augment our thriving organic business, and create value for shareholders over the short and long terms."
Fourth Quarter and Full Year Financial Results
Product revenue grew 43% year-over-year for the fourth quarter of 2015, and 16% for the full year of 2015. The Company saw normal inventory purchase growth patterns resume in the fourth quarter after the conclusion of an inventory rebalancing by its U.S. commercial partner.
Total revenue for the fourth quarter of 2015 increased 33% to $30.9 million, compared to $23.3 million for the fourth quarter of 2014. The increase was primarily driven by the continued growth in Anika's viscosupplementation franchise worldwide. Total revenue for the full year of 2015 was $93.0 million, compared to $105.6 million for the full year of 2014. The decline was due to the receipt of $30 million of licensing, milestone and contract revenue related to MONOVISC product approval, launch, and achievement of a unique CMS reimbursement code in 2014, which was partially offset by $5 million of milestone revenue received in 2015 for the achievement of a target MONOVISC U.S. end user sales threshold.
ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment. Overall, there was a 24% increase in the combined U.S. viscosupplementation end-user revenue in 2015, with MONOVISC end-user sales more than tripling year-over-year domestically.
The Company received a $5.0 million milestone payment in the fourth quarter of 2015 from its U.S. commercial partner as a result of MONOVISC achieving $50 million in end-user revenue in 2015.
Net income for the fourth quarter of 2015 increased 41% to $11.0 million, or $0.72 per diluted share, compared to $7.8 million, or $0.51 per diluted share, for the fourth quarter of 2014. Net income for the full year of 2015 was $30.8 million, or $2.01 per diluted share, compared to $38.3 million, or $2.51 per diluted share. Full-year 2014 results reflected the favorable impact of the $30 million of licensing, milestone and contract revenue previously discussed.
Recent Business Highlights
The Company made key pipeline, commercial, operational, and financial advancements, including:
The commencement of patient enrollment in the Company's HYALOFAST FastTRACK study. HYALOFAST, a biodegradable scaffold, is used to enable cartilage regeneration in patients suffering from cartilage defects. The FastTRACK study is a prospective, randomized, active treatment-controlled, multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. It will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. We believe HYALOFAST is poised to take a market leadership position.
The decision to pursue CINGAL approval in the U.S. through the New Drug Application pathway, and the approval of CINGAL by Health Canada for the treatment of pain associated with osteoarthritis of the knee.
An agreement with a new commercial partner in China for the commercialization of both MONOVISC and CINGAL.
Ongoing progress with full integration of the Company's global manufacturing operations under one roof in Anika's Bedford, Mass. global headquarters. This integration is intended to accelerate product development and to enable full control of the Company's supply chain.
Full Year 2016 Corporate Outlook
Looking forward to 2016, the Company expects total revenue growth to be in the mid-teen percentage range. The Company also anticipates continued headway on several key initiatives including:
Resolution of open items for the submission of CINGAL New Drug Application.
Approval of CINGAL in the E.U. and launch of CINGAL in Canada and Europe.
Advancement toward full patient enrollment in the Company's HYALOFAST FastTRACK study.
Integration of global manufacturing operations in Anika's Bedford, Mass. global headquarters.
Initial occupation of the Company's new Padua, Italy office, which will serve as its new European hub.
Progress in the development of a direct commercialization capability in the U.S.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its financial results, business highlights and financial outlook tomorrow, Thursday, February 25th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the second paragraph, the first and fourth bullet points in the section captioned "Recent Business Highlights," and the section captioned "Full Year 2016 Corporate Outlook" of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company's direct commercialization capabilities, the Company's interest in strategic M&A transactions, enrollment rates in the HYALOFAST clinical study, the commercial potential of HYALOFAST, the integration of the Company's manufacturing operations, the approval of CINGAL in the European Union, and the Company's expected revenue growth. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including (i) the Company's ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST, on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products, including for CINGAL; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operate or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
§
§Three Months Ended December 31, Year Ended December 31,
§ 2015 2014 2015 2014
Product revenue $
25,607
§$ 17,880 $ 87,696 $ 75,474
Licensing, milestone and contract revenue
5,287
§
5,375
§ 5,303 30,121
Total revenue 30,894
23,255
§92,999 105,595
§
Operating expenses:
Cost of product revenue 6,290
5,511
§21,053 20,930
Research & development 3,016
1,984
§8,987 8,144
Selling, general & administrative
4,524
§
3,673
§ 14,825 15,074
Total operating expenses
13,830
§
11,168
§ 44,865 44,148
Income from operations
17,064
§12,087 48,134 61,447
Interest income, net 39 42 120 58
Income before income taxes
17,103
§12,129 48,254 61,505
Provision for income taxes 6,061 4,313 17,496 23,186
Net income $
11,042
§$ 7,816 $ 30,758 $ 38,319
§
Basic net income per share:
Net income $ 0.74 $ 0.53 $ 2.06 $ 2.61
Basic weighted average common shares outstanding 14,965 14,801 14,934 14,678
Diluted net income per share:
Net income $ 0.72 $ 0.51 $ 2.01 $ 2.51
Diluted weighted average common shares outstanding 15,353 15,278 15,321 15,269
§
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
§
§December 31, December 31,
ASSETS 2015 2014
Current assets:
Cash and cash equivalents $ 110,707
§$ 100,156
Investments 27,751 6,750
Accounts receivable, net of reserves of $167 and $147 at December 31, 2015 and 2014, respectively 21,652 17,152
Inventories 14,938 12,407
Prepaid expenses and other current assets 1,385 1,371
Total current assets 176,433 137,836
Property and equipment, at cost 64,648 53,620
Less: accumulated depreciation (24,540 ) (21,951 )
§40,108 31,669
Long-term deposits and other 69 69
Intangible assets, net 11,656 14,895
Goodwill 7,482 8,339
Total Assets $ 235,748 $ 192,808
§
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 8,302 $ 1,201
Accrued expenses and other current liabilities
§4,778 4,772
Income taxes payable 4,198 -
Total current liabilities 17,278 5,973
Other long-term liabilities 781 894
Long-term deferred revenue 66 102
Deferred tax liability 6,775 7,741
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at December 31, 2015 and December 31, 2014 - -
Common stock, $.01 par value; 30,000,000 shares authorized, 15,036,808 and 14,851,703 shares issued and outstanding at December 31, 2015 and 2014, respectively 150 149
Additional paid-in-capital 81,685 77,540
Accumulated other comprehensive loss (6,649 ) (4,495 )
Retained earnings 135,662 104,904
Total stockholders' equity 210,848 178,098
Total Liabilities and Stockholders' Equity $ 235,748 $ 192,808
§
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
§
§
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
§
§Quarter Ended December 31, Year Ended December 31,
§ 2015 % 2014 % 2015 % 2014 %
Orthobiologics $ 21,530 84 % $ 13,207 74 % $ 73,247 84 % $ 61,957 82 %
Surgical 1,363 5 % 1,273 7 % 5,812 7 % 5,855 8 %
Dermal 1,134 5 % 395 2 % 2,266 2 % 1,334 2 %
Other
1,580
§ 6 % 3,005 17 % 6,371 7 % 6,328 8 %
Total Product Revenue $
25,607
§ 100 % $ 17,880 100 % $ 87,696 100 % $ 75,474 100 %
§
Product Gross Profit
§$
19,317
§$
12,369
§$ 66,643 $ 54,544
Product Gross Margin
75§
§% 69 % 76 % 72 %
§
§
Total Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
§
§Quarter Ended December 31, Year Ended December 31,
§ 2015 % 2014 % 2015 % 2014 %
Geographic Location:
§
United States $ 20,574 80 % $ 14,324 80 % $ 71,621 82 % $ 62,606 83 %
Europe 2,462 10 % 936 5 % 8,756 10 % 6,204 8 %
Other
2,571
§ 10 % 2,620 15 % 7,319 8 % 6,664 9 %
Total Revenue $
25,607
§ 100 % $ 17,880 100 % $ 87,696 100 % $ 75,474 100 %
29.02.16 15:38
#13
TasTea
Zahlen u Konferenzcall
Zahlen sind besser als erwartet!
Wenn man die Zahlen genau anschaut sieht man, dass
2014 für Produktumsatz von 75 ,474 Mio Kosten von 44,148 Mio und
2015 für Produktumsatz von 87,696 Mio Kosten von 44,865 angefallen sind.
d.h. der Mehrumsatz schlägt sich zu 90 % als Mehrertrag nieder.
für 2016 rechnen sie mit einem Umsatzwachstum von ca. 15% entspricht ungefahr 13 Mio
wenn ich nun damit rechne, dass 10 Mio davon Gewinn bleiben ( 30 +10 ) : Aktien 14,9 Mio, komme ich für 2016 auf ein eps von 2,67;
Dazu kommt das sie ein Aktienrückkaufprogramm starten für 25 Mio ( dürfte reichen um mind. 500000 Stück zu erwerben), da sie ja keine Schulden haben und der ganze Gewinn als Cash hängen bleibt.
Dann könnte der Gewinn per Aktie Richtung 2,80 gehen.
Offizieles neues Kursziel vor den Zahlen war 51$, erwartet wurden dabei ein eps fürs 4.Q von 0,62$ (tatsächlich 0,72$)
Conferenz Call:
- Aktienrückkaufprogramm für 25 Mio
- Firmenzukauf geplant um Synergieeffekte zu heben: kann sein im Vertrieb, Produktion oder ergänzende Produkte/ Dienstleistung
- eigener Vertrieb wird wie gesagt selber aufgebaut
- Gespräche zur Zulassung von Cingal in den USA laufen - genauere Aussagen in 1-2 Monaten erwartet
- Zulassung für Monovisc für die Behandlung der Hüfte wird beantragt
- Monovisc und Orthovisc sollen ab 2017 in den USA Marktführer sein
- Umsatzwachstum von ca. 15 % erwartet
- zusätzlich ist zum Jahresende eine weitere Meilensteinzahlung möglich (2015 waren es 5 Mio $)
- Ausbau des Produktvertriebes für Monovisc u Orthovisc in China und Japan - dauert allerdings ca. 3 Jahre bis davon Umsätze kommen
- Hyalofast ( zur Knorpelreparatur und Regeneration- etwas vergleichbares gibt es bis jetzt nicht, die Behandlung mit Hyalofast ist billiger und besser als vergleichbare bisherige Behandlungen)
Zulassungsverfahren läuft;
Zusammenfassung des CEO: Anika hat stabiles und sicheres Wachstum für die kommenden Jahre vor sich = long term buy!
Wenn man die Zahlen genau anschaut sieht man, dass
2014 für Produktumsatz von 75 ,474 Mio Kosten von 44,148 Mio und
2015 für Produktumsatz von 87,696 Mio Kosten von 44,865 angefallen sind.
d.h. der Mehrumsatz schlägt sich zu 90 % als Mehrertrag nieder.
für 2016 rechnen sie mit einem Umsatzwachstum von ca. 15% entspricht ungefahr 13 Mio
wenn ich nun damit rechne, dass 10 Mio davon Gewinn bleiben ( 30 +10 ) : Aktien 14,9 Mio, komme ich für 2016 auf ein eps von 2,67;
Dazu kommt das sie ein Aktienrückkaufprogramm starten für 25 Mio ( dürfte reichen um mind. 500000 Stück zu erwerben), da sie ja keine Schulden haben und der ganze Gewinn als Cash hängen bleibt.
Dann könnte der Gewinn per Aktie Richtung 2,80 gehen.
Offizieles neues Kursziel vor den Zahlen war 51$, erwartet wurden dabei ein eps fürs 4.Q von 0,62$ (tatsächlich 0,72$)
Conferenz Call:
- Aktienrückkaufprogramm für 25 Mio
- Firmenzukauf geplant um Synergieeffekte zu heben: kann sein im Vertrieb, Produktion oder ergänzende Produkte/ Dienstleistung
- eigener Vertrieb wird wie gesagt selber aufgebaut
- Gespräche zur Zulassung von Cingal in den USA laufen - genauere Aussagen in 1-2 Monaten erwartet
- Zulassung für Monovisc für die Behandlung der Hüfte wird beantragt
- Monovisc und Orthovisc sollen ab 2017 in den USA Marktführer sein
- Umsatzwachstum von ca. 15 % erwartet
- zusätzlich ist zum Jahresende eine weitere Meilensteinzahlung möglich (2015 waren es 5 Mio $)
- Ausbau des Produktvertriebes für Monovisc u Orthovisc in China und Japan - dauert allerdings ca. 3 Jahre bis davon Umsätze kommen
- Hyalofast ( zur Knorpelreparatur und Regeneration- etwas vergleichbares gibt es bis jetzt nicht, die Behandlung mit Hyalofast ist billiger und besser als vergleichbare bisherige Behandlungen)
Zulassungsverfahren läuft;
Zusammenfassung des CEO: Anika hat stabiles und sicheres Wachstum für die kommenden Jahre vor sich = long term buy!
03.05.18 17:14
#14
Vassago
ANIK 33,04$
Anika Therapeutics meldet Ergebnisse für Q1/18
http://ir.anikatherapeutics.com/news-releases/...18-financial-results
20.06.18 17:48
#15
Vassago
ANIK 29,48$ (-36%)
Phase III Cingal floppt
https://www.fiercebiotech.com/...itis-drug-cingal-flunks-phase-3-test
26.07.18 16:55
#16
Vassago
ANIK 41,25$ (+21%)
Anika Therapeutics meldet Ergebnisse für Q2/18
http://ir.anikatherapeutics.com/news-releases/...18-financial-results
25.07.19 16:54
#17
Vassago
ANIK 53,10$ (+30%)
Anika Therapeutics meldet Zahlen für Q2/19
- Umsatz 30 Mio. $
- Gewinn 9 Mio. $
- EPS 0,67$
https://ir.anikatherapeutics.com/news-releases/...9-financial-results
25.10.19 17:34
#18
Vassago
ANIK 71,37$ (+32%)
Anika Therapeutics meldet Zahlen für Q3/19
- Umsatz 30 Mio. $
- Gewinn 9 Mio. $
- EPS 0,64$
- Umsatzwachstum, Gewinnerwartungen übertroffen, Jahresprognose angehoben
"Based on currently available information, the Company expects total revenue growth to be in the range of 6% to 7% for the full year of 2019."
https://ir.anikatherapeutics.com/news-releases/...9-financial-results
25.10.19 18:37
#19
Balu4u
hab sie leider nur auf der Watchlist
aber die Umsätze sind im Vergleich mit der MK ein Witz. Schaut euch mal Puma Biotech hingegen an, deren Umsätze sind schon höher als die MK. Für mich Puma nach wie vor unterbewertet.
21.02.20 15:46
#20
Vassago
ANIK 43,09$ (+3%)
Zahlen für Q4/19 und FY19
- Umsatz 115 Mio. $ (VJ 106)
- Q4 Umsatz 30 Mio. $ (VJQ 27)
- Q4 Umsatz 30 Mio. $ (VJQ 27)
- Gewinn 27 Mio. $ (VJ 19)
- Q4 Gewinn 4 Mio. $ (VJQ 8)
- Q4 Gewinn 4 Mio. $ (VJQ 8)
- EPS 1,89$ (VJ 1,27$)
- Q4 EPS 0,28$ (VJQ 0,54$)
- Q4 EPS 0,28$ (VJQ 0,54$)
- FY20 Umsatz Ausblick 160-165 Mio. $
- Gewinn 5-12 Mio. $
https://ir.anikatherapeutics.com/news-releases/...year-2019-financial
03.06.20 15:27
#21
Vassago
ANIK 34.84$
Zahlen für Q1/20
- Umsatz 35 Mio. $
- Gewinn 3 Mio. $
- EPS 0,24$
- FY20 Ausblick wegen Corona zurückgezogen
- MK 495 Mio. $
https://ir.anikatherapeutics.com/news-releases/...0-financial-results
05.11.20 10:09
#22
Vassago
ANIK 36.77$
Zahlen für Q3/20
- Umsatz 32 Mio. $
- Verlust 6 Mio. $
- Cash 125 Mio. $
- MK 522 Mio. $
https://ir.anikatherapeutics.com/news-releases/...0-financial-results
12.03.22 10:10
#23
Vassago
ANIK 25.48$
Zahlen für Q4/21
- Umsatz 36 Mio. $
- Verlust 6 Mio. $
- Cash 94 Mio. $
- MK 369 Mio. $
"the Company expects its overall revenue for fiscal year 2022 to be up low to mid-single digit percent compared with 2021"
https://ir.anikatherapeutics.com/news-releases/...1-financial-results
19.04.22 09:27
#24
Vassago
ANIK 22.47$ (neues 52 WT)
Das Umsatzwachstum scheint sich abzuflachen. ANIK pendelt um den Break-Even.
11.08.23 12:04
#25
Vassago
ANIK 18.58$ (-7%)
Zahlen für Q2/23
- Umsatz 44 Mio. $
- FY23 Umsatzausblick 159,5-163 Mio. $
- FY23 Umsatzausblick 159,5-163 Mio. $
- Verlust 3 Mio. $
- Cash 65 Mio. $
- MK 274 Mio. $
https://ir.anika.com/...Reports-Second-Quarter-2023-Financial-Results